BENICAR HCT Drug Patent Profile

When do Benicar Hct patents expire, and when can generic versions of Benicar Hct launch?

Benicar Hct is a drug marketed by Cosette and is included in one NDA.

The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Benicar Hct

A generic version of BENICAR HCT was approved as hydrochlorothiazide; olmesartan medoxomil by ALKEM LABS LTD on July 11^th, 2024.

Summary for BENICAR HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	17
Drug Prices:	Drug price information for BENICAR HCT
Drug Sales Revenues:	Drug sales revenues for BENICAR HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENICAR HCT
What excipients (inactive ingredients) are in BENICAR HCT?	BENICAR HCT excipients list
DailyMed Link:	BENICAR HCT at DailyMed

See drug prices for BENICAR HCT

See drug sales revenues for BENICAR HCT

Recent Clinical Trials for BENICAR HCT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
EMS	Phase 3
Daiichi Sankyo Co., Ltd.	N/A
Chinese PLA General Hospital	Phase 4

See all BENICAR HCT clinical trials

Pharmacology for BENICAR HCT

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for BENICAR HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	20 mg/12.5 mg	021532	1	2007-05-11
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	40 mg/12.5 mg and 40 mg/25 mg	021532	1	2007-02-15

US Patents and Regulatory Information for BENICAR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	AB	RX	Yes	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	AB	RX	Yes	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	AB	RX	Yes	Yes

Expired US Patents for BENICAR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	5,616,599*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	5,616,599*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	6,878,703*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	6,878,703*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	5,616,599*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	6,878,703*PED

International Patents for BENICAR HCT

See the table below for patents covering BENICAR HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	324890
China	1045770
Norway	2011013
Luxembourg	91056
Hungary	9200578
Hong Kong	1011361

Supplementary Protection Certificates for BENICAR HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0503785	C00503785/03	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0503785	SPC/GB03/024	United Kingdom		PRODUCT NAME: OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHAMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 50202.00.00 20020813; DE 50202.01.00 20020813; DE 50202.02.00 20020813; DE 50205.00.00 20020813; DE 50205.01.00 20020813; DE 50205.02.00 20020813; UK PL 08265/0015 20030522; UK PL 08265/0016 20030522; UK PL08265/0017 20030522
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0503785	CA 2009 00015	Denmark		PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
0503785	9/2011	Austria		PRODUCT NAME: KOMBINATION AUS OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, AMLODIPIN BESILAT UND HYDROCHLOROTHIAZID; NAT. REGISTRATION NO/DATE: 1-30068 - 1-30072 20110216; FIRST REGISTRATION: DE 79810.00.00 - 79814.00.00, UND 79815.00.00 - 79819.00.00 20101216

BENICAR HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benicar HCT

Introduction

Benicar HCT, a combination drug containing olmesartan medoxomil and hydrochlorothiazide, is marketed by Daiichi Sankyo Inc. for the treatment of hypertension. This article delves into the market dynamics and financial trajectory of Benicar HCT, including its launch, market performance, legal challenges, and financial impacts on Daiichi Sankyo.

Launch and Market Approval

Benicar HCT received marketing approval from the U.S. Food and Drug Administration (FDA) in June 2003. It is indicated for the treatment of hypertension and can be used alone or in combination with other antihypertensive agents, although it is not recommended for initial therapy in pediatric patients[4].

Market Performance

Following its launch, Benicar HCT became a significant player in the antihypertensive market. The drug's effectiveness in reducing blood pressure, with mean reductions of systolic blood pressure by 18 mm Hg and diastolic blood pressure by 13 mm Hg at the maximum recommended dose, contributed to its market success[4].

In fiscal 2009, Benicar and Benicar HCT combined sales were substantial, with Benicar HCT contributing to the overall revenue of Daiichi Sankyo. The company aimed to boost sales of these drugs as part of its global product lineup, particularly in Japan, the U.S., and Europe[3].

Marketing and Promotion

Daiichi Sankyo and its co-promoter, Forest Laboratories, invested heavily in promoting Benicar and Benicar HCT. Between 2002 and 2008, they spent approximately $1 billion on promotional activities, which helped the drugs become top sellers. However, these marketing efforts were later criticized for omitting serious risks associated with the medication[1].

Legal Challenges

The success of Benicar HCT was marred by legal challenges. In 2014, the first federal lawsuits were filed against Daiichi Sankyo, alleging that the company failed to warn patients about the risk of sprue-like enteropathy, a condition that causes severe diarrhea and weight loss. These lawsuits were consolidated into multidistrict litigation (MDL) No. 2606, which also included other drugs containing olmesartan, such as Benicar and Tribenzor[1].

In 2017, Daiichi Sankyo and Forest Laboratories agreed to a $300 million settlement to compensate over 2,000 patients for their injuries. The FDA had previously warned that drugs containing olmesartan could cause sprue-like enteropathy, and the agency had ordered corrective actions, including the discontinuation of certain promotional materials and the provision of corrective messages to physicians[1].

Financial Impact

The legal settlements and regulatory actions had significant financial implications for Daiichi Sankyo. The $300 million settlement in 2017 was a substantial expense, and the company also faced costs associated with the corrective actions mandated by the FDA.

Despite these challenges, Benicar HCT continued to generate revenue for Daiichi Sankyo. However, the drug's sales were affected by the legal issues and the increasing competition in the antihypertensive market. In the annual reports, Daiichi Sankyo noted the impact of drug price revisions and the promotion of generic drugs, which influenced the sales of Benicar HCT and other branded drugs[3].

Financial Performance Metrics

• Revenue: In fiscal 2009, Benicar and Benicar HCT combined sales contributed significantly to Daiichi Sankyo's revenue. For example, in Japan, the sales of these drugs were part of the company's target to achieve ¥1,150 billion in net sales by fiscal 2012[3].
• Operating Profit: The legal settlements and regulatory issues affected the operating profit of Daiichi Sankyo. The company reported a decrease in operating profit in certain years due to these special items[2].
• R&D Expenses: Daiichi Sankyo continued to invest in research and development, which included efforts to manage the lifecycle of products like Benicar HCT. R&D expenses remained a significant component of the company's financials[2].

Market Expansion and Lifecycle Management

Daiichi Sankyo implemented various strategies to manage the lifecycle of Benicar HCT and maintain its market presence. This included launching combination products, such as Rezaltas in Japan, which combined olmesartan with a long-acting calcium channel blocker. The company also focused on global sales expansion and the introduction of new products to offset the impact of generic competition[3].

Conclusion

The market dynamics and financial trajectory of Benicar HCT are complex, influenced by both the drug's clinical efficacy and the legal and regulatory challenges it faced. Despite significant revenue generation, the drug's success was tempered by costly legal settlements and regulatory actions. Daiichi Sankyo's financial performance was impacted, but the company continued to manage the lifecycle of Benicar HCT and explore new market opportunities.

Key Takeaways

• Market Approval and Performance: Benicar HCT was approved by the FDA in 2003 and became a significant player in the antihypertensive market.
• Legal Challenges: The drug faced lawsuits over the risk of sprue-like enteropathy, leading to a $300 million settlement.
• Financial Impact: Legal settlements and regulatory actions affected Daiichi Sankyo's financial performance.
• Lifecycle Management: The company implemented strategies to manage the lifecycle of Benicar HCT and maintain market presence.
• Global Sales: Benicar HCT contributed to Daiichi Sankyo's global sales targets, particularly in Japan, the U.S., and Europe.

FAQs

1. What is Benicar HCT used for? Benicar HCT is used for the treatment of hypertension and can be used alone or in combination with other antihypertensive agents[4].

2. When was Benicar HCT approved by the FDA? Benicar HCT was approved by the FDA in June 2003[4].

3. What were the legal challenges faced by Benicar HCT? The drug faced lawsuits alleging that the manufacturer failed to warn patients about the risk of sprue-like enteropathy, leading to a $300 million settlement in 2017[1].

4. How did the legal issues impact Daiichi Sankyo's financials? The legal settlements and regulatory actions affected Daiichi Sankyo's operating profit and overall financial performance, with a significant expense incurred from the $300 million settlement[1][2].

5. What strategies did Daiichi Sankyo use to manage the lifecycle of Benicar HCT? The company launched combination products, focused on global sales expansion, and introduced new products to maintain market presence and offset generic competition[3].

Sources

1. DrugWatch - Benicar Lawsuits | Blood-Pressure Drug Injuries Alleged
2. Daiichi Sankyo - Reference Data
3. Daiichi Sankyo - Annual Report 2010
4. Daiichi Sankyo - BENICAR® Fact Sheet